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AMG 595

Phase 1

Advanced Malignant Glioma | Small molecule | Oncology |Amgen Inc.|Last Updated: Apr 15, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01475006AMG 595 First-in-Human in Recurrent GliomasPHASE1 COMPLETED 32 — — Feb 1, 2012Apr 1, 2016Apr 15, 20164 United States, Australia
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Study Endpoints
Primary Endpoints
Clinically significant or > or = to Grade 3 CTCAE changes in safety laboratory tests, physical exams, ECGs or vital signs
28 Days after last subject enrolled of each cohort in Part 1 and every 10, 20 and 30 subject enrolled in part 2 (if available)
PK Parameters: Cmax, Cmin, and if feasible half life - 8 time points up to 6 weeks
28 Days after last subject enrolled of each cohort in Part 1 and every 10, 20 and 30 subject enrolled in part 2 (if available)
Objective response in GBM tumors as assessed by Macdonald criteria
3 years
Dose limiting toxicity used to estimate the MTD
28 Days after last subject enrolled of each cohort in Part 1 and every 10, 20 and 30 subject enrolled in part 2 (if available)
Secondary Endpoints
Clinical benefit rate
every 6 months
Progressive free survival
3 years
Overall survival
3 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part I Dose ExplorationEXPERIMENTALPre-specified nominal doses are proposed in the dose exploration. Intermediate doses may also be used if required based on the CRM design.
Part II Dose ExpansionEXPERIMENTALDose selected from Part 1 dose exploration
Interventions
NameTypeDescription
AMG 595DRUGAMG 595 is an antibody drug conjugate that binds to EGFRvIII.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Karnofsky performance score \> or = 70% * Must have pathologically documented, and definitively diagnosed recurrent WHO Grade IV advanced malignant glioblastoma multiforme (Part 1 and Part 2) and/or WHO Grade III anaplastic astrocytoma (Part 1 only). * GBM and/or AA tumors exp...

Countries:United StatesAustralia
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